Tobacco SmokingNCT02841683
Pragmatic Randomised Controlled Trial Evaluating Effectiveness of a Smoking Cessation e- Intervention " Tabac Info Service "
A study testing Tabac Info Service in people with Tobacco Smoking, run by Ecole des Hautes Etudes en Santé Publique at 1 site in France.
Trial summary
Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Tabac Info Service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,806 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult smokers
- with an information and consent form completed
- agreed to participate in the study
- get a Smartphone and be willing to use applications
- wanting stop smoking (in short, medium or long terms).
Who cannot join
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effectiveness of Tabac Info Service (EE-TIS)
Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. This paper presents the study protocol of the evaluation of the program. The primary objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of use, social or environmental contextual factors likely to influence the efficacy of eTIS, and the behavior change techniques (BCTs).
Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial including a process evaluation with at least 3000 participants randomized to the intervention or to the control arm (current practices presented in a non-interactive website). Inclusion criteria are: Adults, Smokers with an information and consent form completed, Getting a smartphone and using mobile applications, wanting stop to smoking in short, medium or long terms. The exclusion criterion is the refusal to participate in the study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence abstinence of 30 days at 12 months later, number of quit attempts during the study, progression of stages within the program (changes and duration in each stage). Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression will be carried out to estimate an OR [95% confidence interval] for efficacy. A multivariate multilevel analysis will explore the influence of patients' characteristics, social and environmental context, conditions of use and behavior change techniques on results.
Dissemination -The findings of this study will allow us to understand and characterize the efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological, environmental and contextual factors, which could influence the efficacy of this type of intervention on smokers. These findings will be disseminated through peer-reviewed journals, national and international conference presentations and public events.
- Conditions
- Tobacco Smoking
- Being tested
- Tabac Info Service
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tabac Info ServiceBehavioural
A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application Receives: Behavioral: Tabac Info Service |
| Current practices | No intervention | Current practices of smoking cessation in France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence of 7 days
Measured: 6 months
Secondary outcomes (6)
continuous abstinence rate
Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint
Measured: 6 months
continuous abstinence rate
Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint
Measured: 12 months
minimum 24-hour point abstinence
Measured: 3 months
minimum 30-day point abstinence
Measured: 12 months
number of quit attempts
Measured: 6 months
total duration of quit attempts
calculated as sum of days with no use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start1 Sep 2017
- Primary completion1 Mar 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecole des Hautes Etudes en Santé Publique
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Cambon, Ecole des Hautes Etudes en Santé Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841683
- Sponsor's protocol ID
- Cnamts_2016_1
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2016
- Last updated
- 24 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Affret A, Luc A, Baumann C, Bergman P, Le Faou AL, Pasquereau A, Arwidson P, Alla F, Cambon L. Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. BMJ Open. 2020 Oct 27;10(10):e039515. doi: 10.1136/bmjopen-2020-039515.
PubMed 33109670Cambon L, Bergman P, Le Faou A, Vincent I, Le Maitre B, Pasquereau A, Arwidson P, Thomas D, Alla F. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial. BMJ Open. 2017 Feb 24;7(2):e013604. doi: 10.1136/bmjopen-2016-013604.
PubMed 28237958
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Tabac Info Service (EE-TIS)
- ClinicalTrials.gov ID
- NCT02841683
- Acronym / sponsor ID
- Cnamts_2016_1
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,806 participants (actual)
- Lead sponsor
- Ecole des Hautes Etudes en Santé PubliqueUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. This paper presents the study protocol of the evaluation of the program. The primary objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of use, social or environmental contextual factors likely to influence the efficacy of eTIS, and the behavior change techniques (BCTs).
Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial including a process evaluation with at least 3000 participants randomized to the intervention or to the control arm (current practices presented in a non-interactive website). Inclusion criteria are: Adults, Smokers with an information and consent form completed, Getting a smartphone and using mobile applications, wanting stop to smoking in short, medium or long terms. The exclusion criterion is the refusal to participate in the study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence abstinence of 30 days at 12 months later, number of quit attempts during the study, progression of stages within the program (changes and duration in each stage). Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression will be carried out to estimate an OR [95% confidence interval] for efficacy. A multivariate multilevel analysis will explore the influence of patients' characteristics, social and environmental context, conditions of use and behavior change techniques on results.
Dissemination -The findings of this study will allow us to understand and characterize the efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological, environmental and contextual factors, which could influence the efficacy of this type of intervention on smokers. These findings will be disseminated through peer-reviewed journals, national and international conference presentations and public events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: Tabac Info ServiceA smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application |
| Current practices | No intervention | –Current practices of smoking cessation in France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult smokers
- with an information and consent form completed
- agreed to participate in the study
- get a Smartphone and be willing to use applications
- wanting stop smoking (in short, medium or long terms).
Key exclusion criteria (1 listed)
- refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tabac Info ServiceA smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application | Behavioural | Lifestyle counseling |
Primary outcome
Point prevalence abstinence of 7 days
Time frame: 6 months
6 secondary outcomes
continuous abstinence rate
Time frame: 6 months
continuous abstinence rate
Time frame: 12 months
minimum 24-hour point abstinence
Time frame: 3 months
minimum 30-day point abstinence
Time frame: 12 months
number of quit attempts
Time frame: 6 months
total duration of quit attempts
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Derived from this study: PubMed 33109670Affret A, Luc A, Baumann C, Bergman P, Le Faou AL, Pasquereau A, Arwidson P, Alla F, Cambon L. Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. BMJ Open. 2020 Oct 27;10(10):e039515. doi: 10.1136/bmjopen-2020-039515.
- Derived from this study: PubMed 28237958Cambon L, Bergman P, Le Faou A, Vincent I, Le Maitre B, Pasquereau A, Arwidson P, Thomas D, Alla F. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial. BMJ Open. 2017 Feb 24;7(2):e013604. doi: 10.1136/bmjopen-2016-013604.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tabac Info Service in people with Tobacco Smoking, run by Ecole des Hautes Etudes en Santé Publique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence abstinence of 7 days (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02841683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.